Safety of biologics for the treatment of asthma in children and adolescents: a systematic review.

contextDespite the clinical benefits, the administration of biologics in asthma is not without adverse effects. However, there is a lack of information on the safety profile, particularly in children.

objectiveTo provide a systematic review of the range of reported adverse events (AEs) of biologic treatments approved for paediatric asthma (Xolair, Nucala, Dupixent, Fasenra and Tezspire). DATA SOURCES: Databases (MEDLINE, CENTRAL, Scopus and Web of Science) and one registry (ClinicalTrials.gov). STUDY SELECTION: This review included randomised clinical trials, prospective clinical studies, real-world studies, exploratory studies, registry analyses, case series and case reports, which met predefined inclusion criteria. DATA EXTRACTION: Study characteristics and AEs were extracted into predefined forms and then summarised in terms of their frequency and study duration.

resultsOverall, 45 reports and 13 clinical trials met the inclusion criteria for data evaluation, of which eight studies were placebo-controlled. Overall, paediatric asthma patients' most frequently reported AEs were headache, injection site reactions, upper respiratory tract infections, pyrexia and urticaria. The systematic analysis revealed a similar safety profile of the biologics to that reported on the product labels. LIMITATIONS: The small number of paediatric patients, missing placebo control groups, variant definitions of AEs and a lack of statistical evaluation limited the validation of specific AEs to individual biologics.

conclusionsIn this systematic review, no new safety concerns regarding the use of biologics in paediatric asthma were identified, even after an observation period of up to 7 years. In order to record rare side-effects and possible long-term consequences, further data from paediatric study cohorts are needed.